Phase 4
N=401
Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke
Cerebral Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00200356 ↗Enrolled (actual)
401
Serious AEs
14.0%
Results posted
Jan 2013
Primary outcome: Primary: the Rate of Patients With a Modified Rankin Scale Score of 0-1 — 109; 98; 46; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Edaravone (Drug); Sodium Ozagrel (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Rate of Patients With a Modified Rankin Scale Score of 0-1 |
109; 98; 46; 39; 63; 59 | — |
| SECONDARY Barthel Index Score |
148; 133 | — |
| SECONDARY Baseline NIH Stroke Scale Score |
3.7; 3.8 | — |
| SECONDARY NIH Stroke Scale Score at 14 Days |
98; 108 | — |
| SECONDARY NIH Stroke Scale Score at 1 Month |
117; 119 | — |
| SECONDARY NIH Stroke Scale Score at 3 Months |
135; 140 | — |
| SECONDARY Japan Stroke Scale (Motor Function) Score at 14 Days |
4.521; 4.686 | — |
| SECONDARY Japan Stroke Scale (Motor Function) Score at 1 Month |
3.632; 3.680 | — |
| SECONDARY Japan Stroke Scale (Motor Function) Score at 3 Months |
2.507; 2.927 | — |
| SECONDARY Modified Rankin Scale Score |
112; 108 | — |
Summary
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
Eligibility Criteria
Inclusion Criteria
- Patients can be receive drug treatment within 24 hours after stroke onset
- Patients with a level of consciousness between 0 (alert) and 3 (unable to recall name and date of birth) according to the Japan Coma Scale
- Patients with motor dysfunction of upper and/or lower extremities
- Patients aged 20 years or older when giving informed consent
Exclusion Criteria
- Serum creatinine of >1.5 mg/dL
- Embolic infarction
- Intracranial haemorrhage
- Large infarction with severe consciousness
- Transient ischemic attack (TIA)
- A modified Rankin Scale score of ≥2 before stroke onset
- Patients were receive drug treatment (argatroban, urokinase, tissue plasminogen activator, heparin, warfarin sodium, aspirin, ticlopidine hydrochloride, cilostazol, edaravone and sodium ozagrel) after stroke onset
- Patients were receive surgical treatment or intravascular treatment
- With severe complications (cirrhosis, heart failure, etc.)
- Treating malignant tumor
- Pregnant or possibly pregnant women, nursing mothers
- History of edaravone, sodium ozagrel and ozagrel hydrochloride sensitivity
- Less than 3 months since any other clinical trial or postmarketing study
Data sourced from ClinicalTrials.gov (NCT00200356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.